Phase 3
N=426
Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00453063 ↗Enrolled (actual)
426
Serious AEs
0.0%
Results posted
May 2010
Primary outcome: Primary: Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 — 9.83; 9.69; -2.36; -1.71 units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- mometasone furoate (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 |
9.83; 9.69; -2.36; -1.71 | 0.001 sig |
| PRIMARY Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 |
7.07; 7.01; -1.52; -1.36 | 0.304 |
| SECONDARY Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 |
2.66; 2.64; -0.54; -0.39 | 0.004 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) |
4.19; 4.42; -1.63; -1.36 | 0.063 |
| SECONDARY Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 |
89.11; 88.85; 10.15; 8.24 | 0.356 |
Summary
This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.
Eligibility Criteria
Inclusion Criteria
- Must be 12 years of age or older, of either sex and of any race.
- Must have at least a 2-year documented history of SAR which exacerbates during the study season.
- Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
- Must be clinically symptomatic at the Screening Visit.
- Must be clinically symptomatic at the Baseline Visit.
- Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
- Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.
Exclusion Criteria
- A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
- A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
- Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
- A subject with rhinitis medicamentosa.
- A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
- A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit.
- A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
- A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Data sourced from ClinicalTrials.gov (NCT00453063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.